SIST EN ISO 7886-4:2010

Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This part of ISO 7886 is not applicable to syringes made of glass (specified in ISO 595), auto-disable syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this part of ISO 7886.

Sterile Einmalspritzen für medizinische Zwecke - Teil 4: Spritzen mit Vorrichtung zur Verhinderung der Wiederverwendung (ISO 7886-4:2006)

Dieser Teil von ISO 7886 legt Anforderungen für sterile Einmalspritzen aus Kunststoff mit oder ohne Kanüle fest, die für das Aufziehen von Flüssigkeiten oder für die Injektion von Flüssigkeiten unmittelbar nach ihrem Befüllen vorgesehen und so gestaltet sind, dass die Spritze nach dem Gebrauch unbrauchbar gemacht werden kann.
Dieser Teil von ISO 7886 ist nicht anwendbar auf Glasspritzen (festgelegt in ISO 595), selbstblockierende Spritzen für die Injektion mit fixer Impfstoffdosis (festgelegt in ISO 7886 3) und zur Vorfüllung ausgelegte Spritzen. Er behandelt nicht die Verträglichkeit mit Injektionsflüssigkeiten. Wenn Spritzen für andere Anwen¬dungsbereiche verwendet werden, können andere als die in diesem Teil von ISO 7886 festgelegten Normen herangezogen werden.
ANMERKUNG   Spritzen, die zur Reduzierung des Verletzungsrisikos durch die Einstichnadel ausgelegt sind, können hinsichtlich ihrer Eigenschaften zur Verhinderung der Wiederverwendung auch mit diesem Teil von ISO 7886 überein¬stimmen. Es ist jedoch festzuhalten, dass andere Eigenschaften der Einstichnadel von Spritzen in diesem Teil von ISO 7886 nicht behandelt werden.

Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif empêchant la réutilisation (ISO 7886-4:2006)

L'ISO 7886-4:2006 spécifie les exigences relatives aux seringues hypodermiques stériles en matière plastique, non réutilisables, avec ou sans aiguille, prévues pour aspirer des liquides ou pour en injecter immédiatement après remplissage, leur conception faisant que la seringue est rendue inutilisable après utilisation.
L'ISO 7886-4:2006 ne s'applique pas aux seringues en verre (spécifiées dans l'ISO 595), aux seringues autobloquantes pour vaccination à dose fixe (ISO 7886-3) et aux seringues conçues pour être préremplies. Elle n'aborde pas le problème de la compatibilité avec les liquides injectables. Si la seringue est utilisée à une autre fin prévue que celle spécifiée dans la présente partie de l'ISO 7886, d'autres normes sont applicables.
NOTE Les seringues conçues pour réduire les risques de blessures dues à des piqûres d'aiguille peuvent également être conformes à la présente partie de l'ISO 7886 en ce qui concerne leurs propriétés empêchant la réutilisation; il est toutefois à souligner que les propriétés de protection contre les piqûres d'aiguilles ne sont pas en tant que telles traitées dans la présente partie de l'ISO 7886.

Sterilne podkožne injekcijske brizge za enkratno uporabo - 4. del: Injekcije, katerih značilnosti preprečujejo ponovno uporabo (ISO 7886-4:2006)

Ta del ISO 7886 določa zahteve za sterilne podkožne injekcijskih brizg za enkratno uporabo z iglo ali brez nje, ki so narejene iz plastičnih materialov in se uporabljajo za aspiracijo tekočin ali injiciranje tekočin takoj po polnitvi ter so tako zasnovane, da injekcijska brizga po uporabi postane neuporabna. Ta del ISO 7886 ne velja za steklene injekcijske brizge (opredeljene v ISO 595), injekcijske brizge za točno določen odmerek imunizacije s sistemom za samouničenje (ISO 7886-3) in injekcijske brizge, ki se polnijo vnaprej. Ne obravnava skladnosti s tekočinami za injiciranje. Kadar se injekcijske brizge uporabljajo v katerikoli drug namen, ki ni naveden v temu delu ISO 7886, lahko veljajo drugi standardi.

General Information

• Status: Withdrawn
• Public Enquiry End Date: 19-Jul-2009
• Publication Date: 15-Dec-2009
• Withdrawal Date: 07-Apr-2019
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 08-Apr-2019
• Due Date: 01-May-2019
• Completion Date: 08-Apr-2019
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 7886-4:2009 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)

Relations

• Replaced By: SIST EN ISO 7886-4:2019 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)
• Effective Date: 01-May-2019
• Replaced By: SIST EN ISO 7886-4:2019 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2018)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 7886-4:2007 - Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
• Effective Date: 01-Jan-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 7886-4:2010
01-januar-2010
1DGRPHãþD
SIST EN ISO 7886-4:2007
6WHULOQHSRGNRåQHLQMHNFLMVNHEUL]JH]DHQNUDWQRXSRUDERGHO,QMHNFLMHNDWHULK
]QDþLOQRVWLSUHSUHþXMHMRSRQRYQRXSRUDER,62
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention
feature (ISO 7886-4:2006)
Sterile Einmalspritzen für medizinische Zwecke - Teil 4: Spritzen mit Vorrichtung zur
Verhinderung der Wiederverwendung (ISO 7886-4:2006)
Seringues hypodermiques stériles, non réutilisables - Partie 4: Seringues avec dispositif
empêchant la réutilisation (ISO 7886-4:2006)
Ta slovenski standard je istoveten z: EN ISO 7886-4:2009
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
SIST EN ISO 7886-4:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 7886-4:2010

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SIST EN ISO 7886-4:2010


EUROPEAN STANDARD
EN ISO 7886-4

NORME EUROPÉENNE

EUROPÄISCHE NORM
September 2009
ICS 11.040.25 Supersedes EN ISO 7886-4:2006
English Version
Sterile hypodermic syringes for single use - Part 4: Syringes with
re-use prevention feature (ISO 7886-4:2006)
Seringues hypodermiques stériles, non réutilisables - Partie Sterile Einmalspritzen für medizinische Zwecke - Teil 4:
4: Seringues avec dispositif empêchant la réutilisation (ISO Spritzen mit Vorrichtung zur Verhinderung der
7886-4:2006) Wiederverwendung (ISO 7886-4:2006)
This European Standard was approved by CEN on 24 August 2009.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7886-4:2009: E
worldwide for CEN national Members.

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SIST EN ISO 7886-4:2010
EN ISO 7886-4:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices .4

2

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SIST EN ISO 7886-4:2010
EN ISO 7886-4:2009 (E)
Foreword
The text of ISO 7886-4:2006 has been prepared by Technical Committee ISO/TC 84 “Devices for
administration of medicinal products and intravascular catheters” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 7886-4:2009.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by March 2010, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 7886-4:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 7886-4:2006 has been approved by CEN as a EN ISO 7886-4:2009 without any modification.

3

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SIST EN ISO 7886-4:2010
EN ISO 7886-4:2009 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
6 1, 7.1, 7.2 – 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
7 1, 7.1, 7.2 – 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
8 1, 7.1, 7.2 – 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
9 1, 7.1, 7.2 – 7.5 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
10 10.1, 10.3
11 1, 10.1, 10.2, 10.3
11.1 1, 10.1, 10.2, 10.3
11.2 1, 10.1, 10.2,
11.3 10.1
12 10.1, 10.2
12.1 10.1, 10.2
12.2 1, 9, 2, 10.2
4

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SIST EN ISO 7886-4:2010
EN ISO 7886-4:2009 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
13.1 1 – 9.2 1, 2, 3, 10.2, 12.8.2
13.2 1 – 9.2, 1, 2, 3 , 10.2, 12.8.2
13.3 10.2
14.1 1, 2
14.2 1, 2, 9.1
15.1 1, 2, 10.1, 10.3
15.2 7.5 – 10.1 E.R. 7.5 is only partially covered:
protection against risks posed by
the presence of phthalates and
other toxic substances are not
specifically addressed.
15.3 1 - 2 - 8.1
15.4 5
15.5 7.1 Only guidance is given
16.1 7.2, 8.3
16.2 7.2, 8.3
17 13.1
17.2.1 a) 13.2 – 13.3 f Except 13.3 (f) (second phrase
regarding indication of single use
consistent across community)
17.2.1 b) 13.2
17.2.1 c) 13.3 a Except 13.3 (a) (regarding
representative in the
Community)
17.2.1 d) 13.2 – 13.3 c
17.2.1 e) 13.2 – 13.3 d
17.2.1 f) 13.2 – 13.3 e
17.2.1 g) 13.3 b
17.2.2 a) 13.2 – 13.3 f Except 13.3 (f) (second phrase
regarding indication of single use
consistent across community)
17.2.2 b) 13.2
17.2.2 c) 13.3 a Except 13.3 (a) (regarding
representative in the
Community)
17.2.2 d) 13.2 – 13.3 c
17.2.2 e) 13.2 – 13.3 d
17.2.2 f) 13.2 – 13.3 e
17.2.2 g) 13.3 b
17.3 a) 13.2 – 13.3 f Except 13.3 (f) (second phrase
regarding indication of single use
consistent across community)
5

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SIST EN ISO 7886-4:2010
EN ISO 7886-4:2009 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
17.3 b) 13.2
17.3 c) 13.3 a Except 13.3 (a) (regarding
representative in the
Community)
17.3 d) 13.2 – 13.3 c
17.3 e) 13.2 – 13.3 d
17.3 f) 13.2 – 13.3 e
17.3 g) 13.3 b
17.3 h) 13.3 k
17.3 i) 13.3 k
17.3 j) 13.3 i
nd
17.3 k) 13.6 Except 13.6 (h) – 2 phrase NA,
feature to prevent re-use is part
of the design and
except 13.6 (q) (regarding date
of issue or latest revision of
instructions for use)
17.3 l) 13.3 b
17.4 a) 13.3 b
17.4 b) 13.2
17.4 c) 13.2 – 13.3 d
17.4 d) 13.2 – 13.3 e
17.4 e) 13.2 – 13.3 c
17.4 f) 13.3 a Except 13.3 (a) (regarding
representative in the
Community)
17.4 g) 13.3 i
17.4 h) 13.3 b
NOTE 6 a Requirement on clinical
evaluation not covered by this
standard

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.


6

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SIST EN ISO 7886-4:2010


INTERNATIONAL ISO
STANDARD 7886-4
First edition
2006-10-01


Sterile hypodermic syringes for single
use —
Part 4:
Syringes with re-use prevention feature
Seringues hypodermiques stériles, non réutilisables —
Partie 4: Seringues avec dispositif empêchant la réutilisation




Reference number
ISO 7886-4:2006(E)
©
ISO 2006

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SIST EN ISO 7886-4:2010
ISO 7886-4:2006(E)
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ii © ISO 2006 – All rights reserved

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SIST EN ISO 7886-4:2010
ISO 7886-4:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Nomenclature . 2
5 Types of syringe . 2
6 Cleanliness . 2
7 Limits for acidity or alkalinity . 2
8 Limits for extractable metals . 2
9 Lubricant. 4
10 Tolerance on graduated capacity. 4
11 Graduated scale . 4
12 Barrel. 4
13 Piston/plunger assembly . 4
14 Syringe nozzle/needle . 5
15 Performance . 5
16 Packaging . 6
17 Labelling . 6
Annex A (normative) Method for preparation of extracts . 9
Annex B (normative) Test method for testing re-use prevention feature for RUP syringes . 10
Annex C (informative) Environmental aspects. 11
Bibliography . 12

© ISO 2006 – All rights reserved iii

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SIST EN ISO 7886-4:2010
ISO 7886-4:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 7886-4 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal
products and intravascular catheters, Subcommittee SC 1, Syringes, needles and intravascular catheters for
single use.
ISO 7886 consists of the following parts, under the general title Sterile hypodermic syringes for single use:
⎯ Part 1: Syringes for manual use
⎯ Part 2: Syringes for use with power-driven syringe pumps
⎯ Part 3: Auto-disable syringes for fixed-dose immunization
⎯ Part 4: Syringes with re-use prevention feature
iv © ISO 2006 – All rights reserved

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SIST EN ISO 7886-4:2010
ISO 7886-4:2006(E)
Introduction
The preparation of this part of ISO 7886 was recognized as a high priority requirement to prevent the re-use of
syringes in the developing and transitional countries. Re-use of injection equipment in the absence of
sterilization has increasingly led to transmission of blood-borne pathogens. See Reference [1] in the
Bibliography.
The World Health Organisation had produced a specification for syringes that are rendered inactive after use
(commonly referred to as “auto-disable” syringes) for fixed dose immunization and syringes with re-use
prevention features for general purpose. Both the WHO and ISO agreed that additional parts of ISO 7886
would be required to cover syringes with re-use prevention features, whilst leaving in place ISO 7886-1 and
ISO 7886-2 without modification, as a large number of devices in common use would not be intended to
comply with the re-use prevention properties suggested.
This part of ISO 7886 is intended to cover syringes that are rendered inoperable after delivery of the intended
dose. These syringes are not covered by ISO 7886-1 and ISO 7886-3. ISO 7886-2 covers syringes used with
power-driven pumps. Given the diversity of clinical applications, the most appropriate re-use prevention
feature offering the highest level of re-use prevention is to be considered for each specific intended use.
It is recognized that syringes designed to reduce the risk of needlestick injuries can also comply with this part
of ISO 7886 with regard to their re-use prevention properties, but it is stressed that anti-needlestick properties
of syringes are not in themselves addressed in this part of ISO 7886.
© ISO 2006 – All rights reserved v

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SIST EN ISO 7886-4:2010

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SIST EN ISO 7886-4:2010
INTERNATIONAL STANDARD ISO 7886-4:2006(E)

Ste
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